01061nas a2200121   4500000000100000008004100001260001500042100002100057245009600078856007200174520067900246022001400925       2026                            d  c2026-01-201 aDonald E. Ingber00aChallenges and opportunities for human Organ Chips in FDA assessments and pharma pipelines,  uhttps://www.sciencedirect.com/science/article/pii/S19345909250045643 aThe Food and Drug Administration recently announced a plan to phase out animal-testing requirements for drug assessments based on advances in new approach methodologies, including human organ-on-a-chip (Organ Chip) microfluidic culture technology. Although Organ Chips are being explored in many pharmaceutical laboratories, they have not yet been integrated into drug-development pipelines. Here, I review challenges that must be overcome to bridge this gap and new opportunities that will emerge. I also discuss additional work that will be required for Organ Chips to reduce animal use, lower drug costs, meet regulatory goals, and improve clinical success in the future.  a1934-5909